Active substanceLornoxicamLornoxicam
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  • Dosage form: & nbspfilm coated tablets
    Composition:

    One film-coated tablet contains:

    active substance: lornoxicam 4 mg or 8 mg;

    Excipients: lactose monohydrate 47.05 mg / 94.1 mg, croscarmellose sodium 3.5 mg / 7 mg, povidone-K30 1.1 mg / 2.2 mg, microcrystalline cellulose 12 mg / 24 mg, magnesium stearate 0.35 mg / 0.7 mg;

    composition of the tablet shell: Hypromellose 0.75 mg / 1.5 mg, titanium dioxide (E171) 0.6 mg / 1.2 mg, talc 0.4 mg / 0.8 mg, dye quinoline yellow (E104) 0.1 mg / 0.2 mg , macrogol-6000 0.15 mg / 0.3 mg.

    Description:Round, biconvex tablets are yellow, covered with a film membrane.
    Pharmacotherapeutic group:NSAIDs
    ATX: & nbsp

    M.01.A.C   Oksikamy

    M.01.A. C.05   Lornoxicam

    Pharmacodynamics:Lornoxicam belongs to the class of oxicams, it has a pronounced analgesic and anti-inflammatory effect. Lornoxicam has a complex mechanism of action, which is based on suppression of prostaglandin synthesis, due to inhibition of cyclooxygenase isoenzymes activity. Besides, lornoxicam inhibits the release of free oxygen radicals from activated leukocytes. The analgesic effect of lornoxicam is not associated with narcotic effects. The drug does not have an opiate-like effect on the central nervous system and, unlike narcotic analgesics, does not depress respiration and does not cause drug dependence.
    Pharmacokinetics:

    Suction. Lornoxicam quickly and almost completely absorbed from the gastrointestinal tract (GIT) after ingestion. In this case, the maximum concentration in the blood plasma is reached after about 1-2 hours. Eating reduces the maximum concentration (CmOh) drug in the blood plasma by 30% and increases the time to reach the maximum concentration (TCmOh) to 2.3 hours. When you re-take the drug in the body does not accumulate. The absolute bioavailability of lornoxicam is 90-100%.

    Metabolism. Lornoxicam is present in the blood plasma mainly unchanged and to a lesser extent in the form of hydroxylated metabolite (3'-hydroxylornoxicam), which does not possess pharmacological activity. Lornoxicam quickly penetrates into the synovial fluid.Area under the curve "concentration-time" (AUC) lornoxicam in the synovial fluid is 0.5 after taking a dose of 4 mg 2 times a day.

    Lornoxicam is completely metabolized in the liver. Isozyme participates in metabolism CYP2C9. The binding of lornoxicam to blood plasma proteins, mainly albumin fraction, is 99% and does not depend on its concentration.

    Excretion. The half-life (T1/2) on the average is 4 hours and does not depend on the concentration of the drug. Approximately 1/3 of the metabolites is excreted from the body by the kidneys and 2/3 - with bile. T1/2 glucuronated metabolites of lornoxicam - about 11 hours.

    In elderly patients, as well as in patients with renal or hepatic insufficiency, no significant changes in the pharmacokinetics of lornoxicam were detected.

    Indications:

    Short-term treatment of pain syndrome of different origin; symptomatic therapy of rheumatic diseases (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, articular syndrome with exacerbation of gout, rheumatic soft tissue damage).

    Contraindications:

    Hypersensitivity to lornoxicam or to one of the components of the drug; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses, and intolerance to acetylsalicylic acid and other NSAIDs (including in history); hemorrhagic diathesis or bleeding disorders, and patients who underwent surgery with a risk of bleeding or incomplete hemostasis; period after aortocoronary shunting; cerebrovascular or other bleeding; erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; recurrent gastric ulcer or recurrent gastrointestinal bleeding; gastrointestinal hemorrhages associated with taking an NSAID in an anamnesis; inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the phase of exacerbation; Decompensated heart failure; severe hepatic impairment or active liver disease; severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease; confirmed hyperkalemia; hypovolaemia or dehydration; deficiency of lactase, lactose intolerance, glucose-galactose malabsorption; pregnancy, the period of breastfeeding; Children under 18 years of age (due to the lack of clinical data on the use of lornoxicam in this age group).

    Carefully:

    Erosion-ulcerative lesions and bleeding from the gastrointestinal tract (in the anamnesis), moderately expressed renal failure, post-surgical conditions, age over 65 years, ischemic heart disease, in patients with hemostasis defects, with the risk of developing cardiovascular thrombosis (myocardial infarction, acute disorders of the brain blood circulation (ischemic, hemorrhagic stroke)), chronic heart failure (II-IV functional class by classification NYHA), cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, systemic lupus erythematosus, creatinine clearance less than 60 ml / min, infection Helicobacter pylori, long-term use of NSAIDs, alcoholism, severe somatic diseases, simultaneous administration of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine , paroxetine, sertraline).

    Pregnancy and lactation:

    The drug is contraindicated during pregnancy.During lactation, breastfeeding should be stopped for the duration of treatment with the drug.

    Dosing and Administration:

    Inside. The drug should be taken before meals, washed down with a glass of water.

    At the expressed painful syndrome the recommended dose is 8-16 mg / day, divided by 2-3 doses. The maximum daily dose is 16 mg.

    With inflammatory and degenerative rheumatic diseases the recommended initial dose is 12 mg. The standard dose is 8-16 mg per day, depending on the patient's condition. The duration of therapy depends on the nature and course of the disease.

    With gastrointestinal diseases. patients with impaired renal or hepatic function, elderly people (over 65 years), after extensive operations, the maximum daily dose is 12 mg, for 3 doses.

    To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.

    Side effects:

    Depending on the frequency of occurrence, the following groups of side effects are identified: very often (≥ 1/10), often (from ≥ 1/100 to <1/10), infrequently (from ≥ 1/1000 to <1/100), rarely from ≥ 1/10000 to <1/1000), very rarely (<1/10000), including individual messages.

    From the nervous system:

    Often: headache, dizziness.

    Infrequent: sleep disorders, depression.

    Rarely: drowsiness, agitation, tremor, paresthesia.

    Very rarely: Aseptic meningitis.

    From the digestive system:

    Often: indigestion, abdominal pain, nausea, vomiting, diarrhea, heartburn.

    Infrequent: gastritis, erosive-ulcerative lesions of the mucosa stomach and intestines (including perforation and bleeding), constipation, flatulence, increased levels of "liver" transaminases.

    Rarely: dry mouth, esophagitis, melena, impaired liver function, stomatitis.

    From the skin:

    Infrequent: skin rash, itching, hives, alopecia.

    Rarely: edematic syndrome, Stevens-Johnson syndrome, Lyell's syndrome, angioedema.

    Very rarely: ecchymosis.

    From the urinary system:

    Rarely: dysuria, decreased glomerular filtration, interstitial nephritis, glomerulonephritis, papillary necrosis, nephrotic syndrome, peripheral edema, acute renal failure.

    From the sense organs:

    Infrequent: noise in the ears.

    Rarely: impaired vision.

    From the cardiovascular system:

    Infrequent: development or exacerbation of heart failure, tachycardia.

    Rarely: increased blood pressure.

    From the hematopoiesis:

    Rarely: agranulocytosis, leukopenia, anemia, thrombocytopenia, increased bleeding time.

    On the part of the respiratory system:

    Infrequently: rhinitis.

    Rarely: pharyngitis, dyspnea, cough, bronchospasm.

    Other:

    Infrequent: anorexia, increased sweating, weight change, arthralgia.

    Rarely: myalgia.

    If any of the side effects listed in the manual are aggravated or you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:

    Symptoms: it is possible to enhance the described side effects.

    Treatment: symptomatic. The intake of activated carbon immediately after taking the drug may help reduce the absorption of lornoxicam. To prevent damage to the mucous membrane of the gastrointestinal tract, you can use antiulcer drugs (analogues of prostaglandins or ranitidine). Hemodialysis is ineffective.

    Interaction:

    Simultaneous application of lornoxicam and:

    - cimetidine increases the concentration of lornoxicam in the blood plasma;

    - anticoagulants or platelet aggregation inhibitors - bleeding time may be longer (increased risk of bleeding, monitoring of the international normalized relationship (MNO) is necessary);

    - beta-blockers and angiotensin-converting enzyme inhibitors can reduce their hypotensive effect;

    - diuretics - reduces the diuretic effect and hypotensive effect;

    - digoxin - reduces renal clearance of digoxin;

    - quinoline antibiotics - increases the risk of convulsive syndrome;

    - other NSAIDs or glucocorticosteroids - increases the risk of gastrointestinal bleeding;

    - mifepristone - lornoxicam can reduce the effectiveness of mifepristone. The drug should be taken no earlier than 8-12 days after taking mifepristone;

    - methotrexate - increases the concentration of methotrexate in the blood plasma;

    - selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline) - increases the risk of gastrointestinal bleeding;

    - lithium salts - can cause an increase in the maximum concentration of lithium in the blood plasma and thereby enhance the known side effects of lithium;

    - cyclosporine - increases the nephrotoxicity of cyclosporine;

    - hypoglycemic agents for oral administration - may enhance the hypoglycemic effect of the latter;

    - alcohol, corticotropin, potassium preparations - increases the risk of GI tract side effects;

    - cefamandole, cefoperazone, cefotetan, valproic acid - increases the risk of bleeding;

    - kolestiramina - accelerates the excretion of lornoxicam from the LCG;

    - rifampicin - reduces the concentration of lornoxicam in the blood plasma.

    Interaction with ranitidine and antacids was not revealed.

    Special instructions:

    The risk of ulcerogenic action of the drug reduces the simultaneous administration of inhibitors of the proton pump and synthetic analogues of prostaglandins. In case of bleeding in the gastrointestinal tract, the drug should be stopped immediately and appropriate emergency measures taken. Especially it is necessary to monitor the condition of those patients with gastrointestinal pathology who are first treated with lornoxicam.

    Like other oxicams, lornoxicam inhibits platelet aggregation and therefore may increase bleeding time. When using this drug, you need to carefully monitor the condition of patients, requiring the absolutely normal functioning of the blood coagulation system (eg, patients,who have a surgical procedure) who have disorders of the blood coagulation system or who receive medications that suppress blood clotting (including heparin at low doses) in order to detect signs of bleeding in a timely manner.

    If there are signs of liver damage (skin itching, yellowing of the skin, nausea, vomiting, abdominal pain, darkening of urine, increased level of "liver" transaminases), stop taking the drug and consult a doctor.

    Do not use the drug simultaneously with other NSAIDs.

    The drug can alter the properties of platelets, but does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

    Patients with impaired renal function caused by large blood loss or severe dehydration, lornoxicam, as an inhibitor of the synthesis of prostaglandins, can be prescribed only after the elimination of hypovolemia and the associated danger of reducing renal perfusion. Like other NSAIDs, lornoxicam can cause an increase in the plasma urea and creatinine plasma levels, as well as water and sodium retention, peripheral edema, arterial hypertension and other early signs of nephropathy.Long-term treatment of such patients with lornoxicam can lead to the following consequences: glomerulonephritis, papillary necrosis and nephrotic syndrome with transition to acute renal failure. Patients with a marked decrease in renal function drug can not be prescribed. In elderly patients, as well as in patients suffering from hypertension and / or obesity, it is necessary to control the level of blood pressure.

    It is especially important to monitor kidney function in elderly patients, as well as in patients:

    - simultaneously receiving diuretics;

    - simultaneously receiving medicines that can cause kidney damage.

    With prolonged use of the drug, it is necessary to periodically monitor hematological parameters, as well as kidney and liver function. The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy.

    Effect on the ability to drive transp. cf. and fur:

    Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require a high concentration of attention and speed of psychomotor reactions,since the drug may cause dizziness and other side effects that may affect these abilities.

    Form release / dosage:

    Tablets film-coated 4 mg, 8 mg.

    Packaging:

    For 10 tablets in a blister of PVC film and aluminum foil. For 3 blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003020
    Date of registration:03.06.2015
    Expiration Date:03.06.2020
    The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India
    Manufacturer: & nbsp
    Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India
    Information update date: & nbsp18.10.2017
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